SUPPLY CHAIN ARTICLES
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Plasmid Production: 3 Key Takeaways For mRNA Manufacturing
Following my latest Live panel on analytical and manufacturing technology innovations for mRNA production, I wanted to provide a few high-level takeaways I gleaned from our discussion on the overlooked darling of the mRNA space: The plasmid.
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Innovations In The Oligonucleotide Supply Chain: Regulatory Considerations For Materials, Manufacturing, And Lifecycle Control
Oligonucleotide therapeutics have rapidly advanced into late-stage and commercial development, shifting regulatory focus toward the maturity of manufacturing and supply chain control rather than therapeutic novelty. Regulatory success now depends on how effectively sponsors translate innovative chemistries into well-characterized, scalable, and sustainable materials and processes.
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Inside Alnylam's Playbook For High Volume siRNA Production
As one of the first companies to establish a chemoenzymatic ligation platform, Alnylam's Maines and Nechev are in the perfect position to espouse wisdom on the practical aspects and remaining challenges of implementing enzymatic ligation at a large scale. Here in this installment, Maines and Nechev outline what they’ve learned thus far about the science of enzymatic ligation, while also paying credence to the unknowns and existing barriers that, as a frontrunner, Alnylam will inevitably (but willingly) be tasked with facing in the future.
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The Expanding Patent Landscape For RNA-Based Therapeutics
The COVID-19 pandemic thrust RNA-based therapeutics into the spotlight. Before that, only a handful had received regulatory approval. Why are RNA-based therapeutics seeing more patent activity now and how should biotech companies mitigate patent risks? Attorneys from Neal Gerber Eisenberg share their insights.
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FDA Sets Recommendations For Predicting Dangerous Nitrosamine Impurities
The FDA recently published a final guidance that sets a recommended framework for predicting the potential of nitrosamine drug substance-related impurities.
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Addressing Challenges In Serialization For Complex Therapeutics
The magnitude of serialization, especially for firms with extensive portfolios and intricate supply chains, poses serious challenges. This discussion offers solutions.
ARTICLES, APP NOTES, CASE STUDIES, & WHITE PAPERS
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Costs of poor quality (COPQ) cannot be overstated. Review the statistics that prove how costly it can be to avoid resolving quality issues in your processes and supply chain.
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Plasmids are crucial for CRISPR-Cas9 gene-editing technology, and their role in CRISPR is expected to evolve with ongoing research.
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Ensuring consistent replication and proper retention of plasmid DNA sequence is vital to the economics and efficiency in generating starting materials used for production of AAV delivered gene therapy and mRNA vaccines and therapeutics.
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Explore ongoing work to harness different types of HDR templates in order to build cutting-edge systems with the potential to enable point-of-care cell and gene therapy manufacture.
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From harsh chemicals to gentle enzymes: Explore the groundbreaking shift in nucleotide synthesis, making drug manufacturing cleaner, greener, and more efficient.
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Explore the past, present, and future of supply chain security, ways the biopharma industry can secure supply chains and minimize risks, and more.
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Uncover how how switching from LAL to rFC can enhance sustainability, improve testing reliability, and strengthen supply-chain resilience in endotoxin testing.